We understand each product has unique sterilization challenges. As a result, REVOX® Services offer a 4-week custom development process to ensure that we address all of your needs. (Click chart below for larger version)
Sterilization Development Process Explanation
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Needs Assessment |
Our technical staff will assess your request and determine the best approach to solve your sterilization challenges |
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Product Evaluation |
We will perform initial run cycles of your product to determine material compatibility, post-sterilization functionality, biocompatibility, and packaging integrity. We also offer express evaluation to help you expedite the evaluation process. |
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Sterilization Proposal |
The proposal is presented with a complete evaluation report, sterilization schedule, delivery options, list of suggested validation testing, and cost. We provide comprehensive information so you are able to make an educated decision. Once we come to agreement on the Sterilization Proposal, you will enter Minntech’s standard Processing Agreement where you will specify your processing specifications and procedures. |
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Protocol Development |
We develop a sterilization cycle, validation test plan and a protocol for your review. Additionally, we perform sterilization test validation to ensure the entire process meets applicable regulatory standards prior to beginning routine cycles. |
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Routine Cycle Begins |
In addition to adhering to your sterilization frequency, we offer flexible time schedules, to accommodate any fluctuations in your supply chain cycles. |
